23.02.2024 – 17:11
Federal Medical Association
Berlin (ots)
“It is an important signal that the Federal Government wants to make Germany more attractive as a location for medical research. However, the top priority must always be the safety and protection of study participants. The Federal Government’s planned establishment of a so-called Federal Ethics Committee with the Medical Research Act “Unfortunately, the Commission does not meet this requirement in any way. In its current form, the law undermines the independence of the assessment of clinical studies and thus damages people’s trust in medical research as a whole.” This is how the President of the German Medical Association Dr. Klaus Reinhardt presented the current draft bill of the Federal Ministry of Health (BMG) for the Medical Research Act.
The location of the Federal Ethics Commission at the Federal Institute for Drugs and Medical Devices, which is subordinate to the BMG depending on instructions, poses a great risk of political and administrative influence. If in the future, in addition to drug approval and monitoring, the evaluation of clinical studies were also assigned to a higher federal authority, possible conflicts of interest could not be reliably ruled out. The planned appointment of the commission members by the Federal Ministry of Health and the necessary approval of the ministry to their rules of procedure also contribute to this. “The independent ethical assessment of research on humans represents an essential cornerstone of patient and test subject protection, especially in light of the experiences from the Nazi era,” said Reinhardt. A weakening of the basic ethical principles for medical research on humans, which were enshrined in the Declaration of Helsinki after the war in the interest of protecting patients and test subjects, would be tantamount to breaking the dam and has the potential to cause considerable damage to social acceptance of medical research.
In the BÄK’s opinion, the structural changes in the draft bill give the impression that the tried and tested system of ethics commissions in Germany established under state law should be fundamentally questioned. “However, it is not clear why – without necessity – the powers of the states are being interfered with in this way and why the functions and competencies are being centralized in the Federal Ministry of Health‘s area of responsibility,” says the BÄK’s written statement on the draft of the Medical Research Act. In addition, the potential for optimization in the existing system of ethics commissions established under state law has not been exhausted.
The BÄK is not alone in its criticism of the Federal Ethics Commission. Since the Federal Government’s plans for a medical research law became known, it has been involved together with scientific institutions, industry and the ethics committees set up under state law in the “Initiative for Study Location Germany (ISD)”, which was set up specifically with a view to the planned medical research law. The ISD also rejects the establishment of a federal ethics commission. Instead, it advocates optimizations in the existing system and makes concrete suggestions in this regard.
In view of the considerable risks involved in implementing the fundamental structural changes set out in the draft bill, the German Medical Association appeals to those responsible to proceed with a sense of proportion and to pursue approaches for further development in the existing system.
Press contact:
Federal Medical Association
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Original content from: German Medical Association, transmitted by news aktuell